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Cerebral Palsy Hip Outcomes Project - International Multi-centre Study

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ClinicalTrials.gov Identifier: NCT01987882
Recruitment Status : Recruiting
First Posted : November 19, 2013
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
The primary purpose of the project is to evaluate the effectiveness of different intervention strategies to prevent or relieve symptoms associated with hip instability in children with severe cerebral palsy, using the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD©) questionnaire as the primary outcome measure of health-related quality of life for this population.

Condition or disease
Cerebral Palsy

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-centre Prospective Comparative Cohort Study
Study Start Date : June 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort
A. "Natural" History or Watchful Waiting
B. Serial Botulinum Toxin Injections +/- Abduction Bracing
C. Adductor (+/- psoas) Muscle Releases Alone
D. Hip Reconstructive Surgery
E. Salvage Hip Surgery



Primary Outcome Measures :
  1. CPCHILD questionnaire: Total Score (0-100) [ Time Frame: Change from baseline to 12 months after treatment ]
    The primary outcome measure will be based at the 12 month assessment. The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.


Secondary Outcome Measures :
  1. CPCHILD Questionnaire: Total Score (0-100) [ Time Frame: Change from baseline to 24 months after treatment ]
    The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.

  2. Reimer's Migration Percentage (MP) [ Time Frame: Change from baseline to 24 months after treatment ]
    The Reimer's Migration Percentage (MP) quantifies the magnitude of the displacement of the femoral head that is uncovered by the acetabulum.

  3. Acetabular Index (AI) in degrees [ Time Frame: Change from baseline to 24 months after treatment ]
    The Acetabular Index (AI) in degrees quantifies the magnitude of acetabular dysplasia.

  4. Morphological Hip Classification in Cerebral Palsy (MHC) [ Time Frame: Change from baseline to 24 months after treatment ]
    The Morphological Hip Classification in Cerebral Palsy (MHC) describes the sphericity of the femoral head.

  5. CPCHILD Questionnaire: Subscale Scores (0 - 100) [ Time Frame: Change from baseline to 24 months after treatment ]

    The Subscale scores of the CPCHILD© questionnaire represent the following domains:

    1. Activities of Daily Living/Personal Care (9 items);
    2. Positioning, Transferring & Mobility (8);
    3. Comfort & Emotions (9);
    4. Communication & Social Interaction (7);
    5. Health (3);
    6. Overall Quality of Life (1).

    Standardized scores are generated on a scale of 0 (worst) to 100 (best) for each of the 6 domains.



Other Outcome Measures:
  1. Adverse Events and Complications [ Time Frame: Adverse events will be recorded up to 24 months after treatment ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) and their parent / primary caregiver will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Children with a working diagnosis of cerebral palsy or cerebral palsy-like condition
  • Between 2 to 18 years of age
  • Has a migration percentage ≥ 30%
  • Non-ambulatory; the primary mode of mobility is a wheelchair
  • Parent/primary caregiver must understand one of the languages in which the CPCHILD has been translated, culturally adapted and validated.

Exclusion Criteria:

  • History of prior hip surgery
  • Received botulinum toxin injection within the previous 3 months. Recruitment will be delayed until at least 3 months after prior botulinum toxin injection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987882


Contacts
Contact: Dr. Unni Narayanan, MBBS, MSc, FRCSC unni.narayanan@sickkids.ca
Contact: Shannon Weir, MSc shannon.weir@sickkids.ca

  Show 27 Study Locations
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children
Investigators
Principal Investigator: Dr. Unni Narayanan, MBBS, MSc, FRCSC Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada

Additional Information:
Publications:
Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01987882     History of Changes
Other Study ID Numbers: 313575
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Outcomes research, treatment effectiveness, quality of life

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases